Ebglyss (lebrikizumab-lbkz) / Roche, Almirall, Eli Lilly - LARVOL DELTA

Lebrikizumab versus Other Systemic Monotherapies for Moderate-to-Severe Atopic Dermatitis: A Network Meta-analysis of Short-term Efficacy (ISAD 2024) - "Treatments for moderate-to-severe atopic dermatitis (AD) after inadequate response to topical therapy include biologics and Ja-nus Kinase (JAK) inhibitors. LEB was statistically superior to baricitinib and tralokinumab, compara-ble to abrocitinib, dupilumab, and upadacitinib 15 mg across all outcomes, but inferior to upadacitinib 30 mg at week-16. LEB has comparable or better short-term efficacy relative to other biologics and JAK inhibitors, except for upadacitinib 30 mg."

Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Atopic Dermatitis-Related Problems in Daily Life, Goals of Therapy and Deciding Factors for Systemic Therapy: A Review. (PubMed, Pharmaceuticals (Basel)) - "Current guidelines and systematic reviews support the safety and efficacy of systemic therapy including conventional drugs (cyclosporine, methotrexate, and azathioprine), biologics (dupilumab and tralokinumab), and JAK inhibitors (baricitinib, upadacitinib, and abrocitinib) recommended for treating moderate and severe AD. Recently, additional biologics have been evaluated in clinical trials, including lebrikizumab, nemolizumab, eblasakimab, and OX40/OX40L, among others...Available data also indicate the importance of a personalized, stepwise, and multidisciplinary approach. This type of approach promotes patient compliance, satisfaction with therapy, and increased engagement, which all lead to better patient outcomes."

Journal • Review • Atopic Dermatitis • CNS Disorders • Depression • Dermatitis • Dermatology • Immunology • Mood Disorders • Psychiatry • Suicidal Ideation • TNFSF4

Improvement in quality of life in patients treated with lebrikizumab monotherapy is mediated by improvement in itch and sleep: Results from two Phase 3 trials in patients with moderate-to-severe atopic dermatitis. (PubMed, Clin Exp Dermatol) - P3 | "We report a post-hoc analysis to quantify the effect of lebrikizumab vs placebo on the Dermatology Life Quality Index (DLQI) mediated indirectly through its effect on patient-reported outcomes itch and itch interference on sleep. Approximately two-thirds of the improvement in DLQI experienced by lebrikizumab-treated patients vs placebo-treated patients at Week 16 was mediated by improvement in itch and the interference of itch on sleep."

HEOR • Journal • Monotherapy • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • IL13

Lebrikizumab: a new anti-IL-13 agent for treating moderate-to-severe atopic dermatitis. (PubMed, Expert Opin Biol Ther) - "Among biologics approved for moderate-to-severe AD, lebrikizumab is characterized by a unique mechanism of action and an attractive maintenance regimen, besides good efficacy and safety profiles. Moreover, clinical evidence suggests that patients naïve or pre-treated with other biologics and affected by AD localized in sensitive areas and by type 2 comorbidities might be successfully treated with lebrikizumab."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL13

Evaluation of Pharmacokinetics of Lebrikizumab in Healthy Individuals After Subcutaneous Administration Using a Prefilled Syringe or Autoinjector in a Phase 1 Randomized Study. (PubMed, Clin Ther) - "Bioequivalence was demonstrated between 250 mg lebrikizumab 2-mL autoinjector and prefilled syringe devices, showing both devices to be suitable options for administering lebrikizumab."

Journal • P1 data • PK/PD data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL13

Correction to: Improvement Across Dimensions of Disease with Lebrikizumab Use in Atopic Dermatitis: Two Phase 3, Randomized, Double-Blind, Placebo-Controlled Monotherapy Trials (ADvocate1 and ADvocate2). (PubMed, Adv Ther) - No abstract available

Clinical • Monotherapy • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and safety of lebrikizumab for the treatment of moderate-to-severe atopic dermatitis: a systematic review and meta-analysis. (PubMed, Front Pharmacol) - "Adverse events (AEs) (RR = 0.984; 95% CI = [0.907, 1.068]) for lebrikizumab showed no statistically significant difference compared to placebo, with similar results for serious adverse events (SAEs) (RR = 0.748; 95% CI = [0.410, 1.364]). This meta-analysis reveals that lebrikizumab has higher efficacy and safety in the treatment of moderate-to-severe AD, with the 250 mg Q2W dosage regimen appearing to be more advantageous."

Clinical • Journal • Retrospective data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • IL13

Efficacy and safety of lebrikizumab combined with topical corticosteroids in Japanese patients with moderate-to-severe atopic dermatitis: a phase 3, double-blind, placebo-controlled, randomized clinical trial (ADhere-J). (PubMed, Curr Med Res Opin) - P3 | "Common treatment-emergent AEs, including pyrexia (placebo: 15.9%; lebrikizumab Q4W/Q2W: 18.5%/20.3%), conjunctivitis allergic (placebo: 4.9%; lebrikizumab Q4W/Q2W: 12.3%/17.1%), and conjunctivitis (placebo: 2.4%; lebrikizumab Q4W/Q2W: 6.2%/9.8%), were more frequent with lebrikizumab; most were mild or moderate. Consistent with global data, lebrikizumab demonstrated clinical improvements with a positive benefit-risk profile in Japanese adults and adolescents with moderate-to-severe AD through 16 weeks."

Clinical • Journal • P3 data • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

AIFA Board Approves Reimbursement of 16 Drugs in November Meeting (NAVLIN DAILY) - "Ebglyss (lebrikizumab): Approved for the treatment of moderate to severe atopic dermatitis in adults and adolescents aged 12 years and older weighing at least 40 kg, who are eligible for systemic therapy...Spevigo (spesolimab): Indicated as monotherapy for the treatment of flares in adult patients with generalized pustular psoriasis (GPP)...Idipulfib (pirfenidone): Expanded indication for the treatment of idiopathic pulmonary fibrosis (IPF) in adults...Pirfenidone viatris (pirfenidone): Expanded indication for the treatment of idiopathic pulmonary fibrosis (IPF) in adults. Pirfenidone zentiva (pirfenidone): Expanded indication for the treatment of idiopathic pulmonary fibrosis (IPF) in adults."

Reimbursement • Atopic Dermatitis • Idiopathic Pulmonary Fibrosis • Immunology • Psoriasis • Pustular Psoriasis

Matching-Adjusted Indirect Comparison of Efficacy and Safety for Lebrikizumab, Dupilumab, and Tralokinumab in Patients With Moderate-to-Severe Atopic Dermatitis Not Adequately Controlled or Non-eligible for Cyclosporine (ISPOR-EU 2024) - "We compared the treatment response achieved during the Week 0-16 induction double-blind period of Lebrikizumab, Dupilumab and Tralokinumab administered biweekly in combination with low- to mid-potency topical corticosteroids in patients with prior cyclosporine A failure or contraindicated. Adjusting for unequal distributions of effect modifiers between trials of AD patients with failed or contraindicated CsA, Lebrikizumab demonstrates equal week 16 efficacy compared to Dupilumab in terms of EASI 75 and IGA 0/1, and statistically superior performance to Tralokinumab for EASI 75 and not statistical superiority in IGA 0/1. Regarding overall Adverse events, Lebrikizumab demonstrates equal RR in front of both comparators."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Lebrikizumab: Completion of P3 Adjoin trial (NCT04392154) in participants with moderate-to-severe atopic dermatitis in Apr 2025 (Eli Lilly) - Q3 2024 Results: Primary completion of P3 Adorable-1 trial (NCT05559359) in participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis in May 2025

Trial completion date • Trial primary completion date • Atopic Dermatitis • Immunology

Indirect Treatment Comparison of Biologic Treatments in Adolescents With Moderate to Severe Atopic Dermatitis: A Systematic Literature Review and Network Meta Analysis (ISPOR-EU 2024) - "Four trials evaluating three drugs, dupilumab, lebrikizumab, and tralokinumab, representing 642 study participants were analyzed. Our findings suggest that dupilumab is the most efficacious biological treatment for AD in adolescents in achieving EASI-75 and IGA Score 0/1 in the short-term. Future studies, ideally a head-to-head trial, are needed to further confirm these results."

Retrospective data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Lebrikizumab: “Lebrikizumab demonstrated meaningful improvement in skin clearance and itch relief in the majority of skin of color patients with moderate-to-severe atopic dermatitis, with 69% of the patients achieving EASI-75 and 45% achieving IGA (0,1) at Week 16”; Atopic dermatitis (Almirall) - Q3 2024 Results

P3 data • Atopic Dermatitis • Immunology

Not Available (PubMed, Arerugi) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

lebrikizumab (Ebglyss) is accepted for restricted use within NHSScotland (Scottish Medicines Consortium) - "Indication under review: for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy. SMC restriction: patients who have had an inadequate response to an existing systemic immunosuppressant such as ciclosporin, or in whom such treatment is considered unsuitable and where a biologic would otherwise be offered. Four phase III studies demonstrated superiority of lebrikizumab in improving signs and symptoms of atopic dermatitis when compared with placebo, as monotherapy or in combination with topical corticosteroids in patients with moderate to severe atopic dermatitis. This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower."

Reimbursement • Atopic Dermatitis

Lilly Canada remains steadfast in commitment to access options for patients amidst controversial CDA-AMC recommendation for Ebglyss (lebrikizumab) (Canada Newswire) - "Eli Lilly Canada Inc...is disappointed and strongly disagrees with Canada's Drug Agency (CDA-AMC)'s Final Recommendation for Ebglyss (lebrikizumab), published on Friday, November 15, 2024. The CDA-AMC recommended that Ebglyss not be reimbursed by public drug plans, excluding Quebec, for the treatment of moderate-to-severe atopic dermatitis (AD) in adults and adolescents 12 years of age and older. Lilly Canada stands behind Ebglyss as a first-line biological therapy for the treatment of atopic dermatitis and we remain committed to patients. Access to Ebglyss for new and existing patients with moderate-to-severe AD via LillyPlus will not change as we tenaciously pursue options for private and public reimbursement in Canada."

Reimbursement • Atopic Dermatitis • Immunology

HADS anxiety and depression scores improved in Japanese patients with moderate-to-severe atopic dermatitis following lebrikizumab treatment: 68-week results from a randomized, double-blind, placebo-controlled Phase 3 trial (ADhere-J) (ISAD 2024) - "LEB+TCS improved anxiety and depressive symptoms in patients with moderate-to-severe AD during the acute treatment phase and maintained these improvements over the maintenance period. This effect seemed more pronounced in W16 responder patients."

Clinical • P3 data • Atopic Dermatitis • CNS Disorders • Depression • Dermatitis • Dermatology • Immunology • Mood Disorders • Psychiatry

Comparative efficacy of targeted systemic therapies for pruritus in moderate-to-severe atopic dermatitis without topical treatment: a network meta-analysis. (PubMed, J Dermatolog Treat) - "The next most effective treatments at the primary endpoint were abrocitinib 200 mg, upadacitinib 15 mg, dupilumab 300 mg, and lebrikizumab 250 mg. Targeted therapies, particularly upadacitinib 30 mg, showed significant advantages in managing moderate-to-severe AD pruritus. Further direct comparative trials are needed for conclusive evidence."

Clinical • Journal • Retrospective data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Health Technology Assessment (HTA) and Reimbursement Decisions for the New Anti-IL-13 Monoclonal Antibody Lebrikizumab for Patients With Moderate to Severe Atopic Dermatitis (AD) in Europe (ISPOR-EU 2024) - "HAS submission aimed at obtaining reimbursement in a subgroup of patients, i.e. with failure, intolerance, or contraindication to ciclosporin, based on an additional targeted efficacy/safety clinical trial of lebrikizumab (ADvantage) performed in this population, and dedicated Matching Adjusted Indirect Comparisons in this population vs dupilumab and tralokizumab. Based on this targeted approach to meet local HTA agencies' requirements, lebrikizumab has been positively recommended for reimbursement in Germany, France, and the United Kingdom. As a result, Almirall has been able to accelerate AD patients’ access to lebrikizumab."

Clinical • Reimbursement • US reimbursement • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL13

IL-13 inhibition in the treatment of atopic dermatitis - new and emerging biologic agents. (PubMed, J Int Med Res) - "Tralokinumab is approved for use in Europe and the USA, while lebrikizumab is approved only in Europe. Cendakimab, which is another IL-13 selective inhibitor, has shown promising results in phase II trials, providing safe and effective outcomes. Eblasakimab, which disrupts IL-13 and IL-4 signaling pathways, is currently in phase II trials following well-tolerated administration in phase I studies. This narrative review aims to outline the current state of knowledge regarding the effectiveness and safety of these four biologic agents targeting IL-13 signaling."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL13 • IL4

Cost-Effectiveness Model of Lebrikizumab Compared to Dupilumab in the Treatment of Austrian Patients With Moderate to Severe Atopic Dermatitis (ISPOR-EU 2024) - "In summary lebrikizumab proves to be economically recommendable compared to dupilumab in a cost advantage over dupilumab in lifelong observation."

Clinical • Cost effectiveness • HEOR • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Lebrikizumab: Primary completion P3 CONTRAST-NP trial (NCT06338995) for chronic rhinosinusitis with nasal polyposis in Nov 2025 (Eli Lilly) - Q3 2024 Results: Completion P3 CONTRAST-NP trial for chronic rhinosinusitis with nasal polyposis in Nov 2025

Trial completion date • Trial primary completion date • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Lebrikizumab: “Over 80% of Week 16 responders experienced sustained skin clearance for up to 3 years”; Atopic dermatitis (Almirall) - Q3 2024 Results

P3 data • Atopic Dermatitis • Immunology

Lebrikizumab-lbkz. (PubMed, Am J Health Syst Pharm) - No abstract available

Journal

Almirall’s Nine-Month 2024 Results: Almirall Reports Strong Performance at Q3 2024 - Driven by Successful Commercial Execution of the Dermatology Portfolio, Fuelled by Biologics Growth (Businesswire) - "The successful launch of Ebglyss in the first markets in Europe generated €20.4 MM in the initial nine months of 2024, representing a 34% sales increase quarter-on-quarter...Total sales of tildrakizumab in the first 9 months of 2024 were €152.5 MM representing a 24.8% growth year-on-year. With its steadily growing market share, Ilumetri has cemented its strong position within the leading class of the Anti-IL 23 psoriasis treatments and is on track to achieve €250 MM peak sales...Almirall´s broad dermatology product portfolio continues to show strong performance growing 17.3% to a total of €404.9 MM in the first nine months of 2024 further driving the company´s relevance to patients and dermatologists. Wynzora grew 62.7% YoY to a total of €19.2 MM, and Klisyri grew 14.0% YoY to a total of €16.4 MM."

Sales • Actinic Keratosis • Atopic Dermatitis • Dermatitis • Immunology • Inflammation • Psoriasis